Monthly Report: New Drug Approvals in China | Sept. 2021

by Grace Wang Oct 25, 2021

Notes: New drug approvals in China covers drugs under the following categories:

  • Innovative new drugs that have never been granted marketing authorization in or outside China;

  • Improved new drugs that have never been granted marketing authorization in or outside China;

  • Original/improved drugs that have received marketing authorization outside China and are applying for marketing authorization in China;

  • First generic drugs or biosimilars in China.

 "First generic drug" refers to the first generic drug/biosimilar to be approved by China’s National Medical Products Administration (NMPA) while its original version has not got marketing authorization in China.

First generics are classified as generic drugs/biosimilars (in contrast with innovative/improved new drugs) according to Chinese drug regulations. Yet, the first generics/biosimilars are still included in this article because they are "new" on the Chinese market.

*Drugs in this article include chemical drugs and biological products.

Perhaps you would like to know the drug classifications in China:

In Sept. 2021, China's NMPA granted 13 new drug approvals:

1. Recombinant Human Growth Hormone for Injection

1

Generic Name

Recombinant Human Growth Hormone for Injection

2

Brand Name

安苏萌 (Pinyin: An Su Meng)

3

Registration Classification

Class 3.2 therapeutic biological product

4

Application Type

Marketing authorization

5

Marketing Authorization Holder (MAH)

Anhui Anke Biotechnology (Group) Co., Ltd.

6

Approval Date

Sept. 13, 2021

7

Time from Application Acceptance to Approval

240 days

8

Priority Review

Yes (reason: pediatric drug)

9

Target

Growth hormone receptor (GHR)

10

Indication(s)  

For idiopathic short stature.

(1) For children:

  • Growth disorders caused by the deficiency of endogenous growth hormone, Turner syndrome, or chronic renal insufficiency.

  • For the treatment of Prader-Willi Syndrome (PWS): facilitate growth and improve body composition. The diagnosis of PWS should be done through proper genetic testing.

(2) For adults:

  • As an alternative therapy, it can be used to treat adults with severe growth hormone deficiency (GHD). Adults with severe GHD refer to adult patients with hypothalamus disorder, pituitary gland disorder or both, and the deficiency of at least one pituitary hormones (except for prolactin).

  • The adult patients should receive a single growth hormone (GH) stimulation test to confirm or exclude GH deficiency.

  • Adult patients should receive two GH stimulation tests if they only had GH deficiency during childhood without disorders of the hypothalamus or pituitary gland or evidence of their heads having got radiated.

  • For patients whose their insulin-like growth factor 1 (IGF-1) concentration's standard difference score is known below 2, they can consider taking single GH stimulation test for only one time.

  • GH stimulation tests shall have strict cut-off values.

11

Notes

First biosimilar in China

2. Dupilumab Injection

1

Generic Name

Dupilumab Injection

2

Brand Name

达必妥 (Dupixent)

3

Registration Classification

Class 3.1 therapeutic biological product

4

Application Type

Supplemental application

5

MAH

Sanofi-Aventis Groupe

6

Approval Date

Sept. 18, 2021

7

Time from Application Acceptance to Approval

257 days

8

Priority Review

No

9

Target

Interleukin 4 Receptor (IL4R)

10

Indication(s)  

Dupixent is indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids.

11

Notes

First biosimilar in China

3. Dupilumab Injection

Grace Wang
ChemLinked Regulatory Analyst
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